BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 2120217 · Received June 6, 2011

    Report

    Report Number
    3008493244-2011-00017
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THEREFORE FAILURE ANALYSIS COULD NOT BE PERFORMED. IT IS UNCLEAR WHAT LED TO THE VESSEL DISSECTION AS NO ISSUES WERE REPORTED WITH THE USAGE OF THE DEVICE. SIMILARLY, THE LOCATION OF THE DISSECTION ON THE VESSEL WALL COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE DISSECTION WAS CAUSED BY THE ARSTASIS DEVICE, THE GUIDEWIRE OR THE INTRODUCER SHEATH. THE ROOT CAUSE FOR THE DISSECTION IS UNKNOWN.

    Description of Event or Problem · 1

    A (B)(6), OVERWEIGHT, MALE, WITH A HISTORY OF CABG WAS UNDERGOING A DIAGNOSTIC ANGIOGRAPHY. DURING THE LATTER PART OF THE PROCEDURE THE PATIENT COMPLAINED OF PAIN IN HIS LEG. A FEMORAL ANGIOGRAM REVEALED A DISCONTINUATION OF FLOW IN THE COMMON FEMORAL ARTERY, PROXIMAL TO THE ENTRY SITE OF THE SHEATH. THE PHYSICIAN ACCESSED THE CONTRALATERAL SIDE AND UNSUCCESSFULLY ATTEMPTED TO CLEAR THE OCCLUSION ON THE SIDE WHERE THE ARSTASIS DEVICE WAS USED. FOLLOWING SEVERAL ATTEMPTS, THE PHYSICIAN CALLED A VASCULAR SURGEON AND THE PATIENT WAS TAKEN TO SURGERY FOR REPAIR OF A DISSECTION OF THE FEMORAL ARTERY. THE PHYSICIAN REPORTED THAT IT WAS NOT POSSIBLE TO DETERMINE WHERE ON THE VESSEL THE DISSECTION HAD OCCURRED. HE ALSO NOTED THERE WAS NOTHING OUTSTANDING ABOUT THE PROCEDURE AND FEMORAL ARTERY WAS UNREMARKABLE WITH NO CALCIFICATION AND NO TORTUOUS ANATOMY. THE PATIENT EXPERIENCED TRANSIENT NEUROLOGICAL SYMPTOMS OF WEAKENING IN HIS LEG DURING RECOVERY AND HE WAS KEPT IN HOSPITAL UNTIL HIS SYMPTOMS RESOLVED. HE WAS DISCHARGED ONCE HE WAS ABLE TO AMBULATE AND NO ADDITIONAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention